EP2460494A1 - Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux - Google Patents

Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux Download PDF

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Publication number
EP2460494A1
EP2460494A1 EP10193368A EP10193368A EP2460494A1 EP 2460494 A1 EP2460494 A1 EP 2460494A1 EP 10193368 A EP10193368 A EP 10193368A EP 10193368 A EP10193368 A EP 10193368A EP 2460494 A1 EP2460494 A1 EP 2460494A1
Authority
EP
European Patent Office
Prior art keywords
lining
endoluminal
cutting
cutting device
acquisition means
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP10193368A
Other languages
German (de)
English (en)
Inventor
David Cagle
Mark Steven Ortiz
Michele D'arcangelo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery Inc
Original Assignee
Ethicon Endo Surgery Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to EP10193368A priority Critical patent/EP2460494A1/fr
Priority to PCT/EP2011/071345 priority patent/WO2012072662A1/fr
Publication of EP2460494A1 publication Critical patent/EP2460494A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30—Surgical pincettes without pivotal connections
    • A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction

Definitions

  • the present invention relates generally to medical apparatuses and methods and more particularly to devices and methods for cutting and removing a lining from a hollow body organ, such as a stomach, intestine, the gastrointestinal tract or any portion thereof.
  • VBG vertical banded gastroplasty
  • Roux-En-Y gastric bypass a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
  • endoluminal sleeves are known for partially or totally lining certain portions of the stomach and of the intestine with the aim to separate or bypass at least part of the food flow from the lined portions of the gastrointestinal tract. It has been observed that by creating a physical barrier between the ingested food and certain regions of the gastrointestinal wall by means of endoluminal sleeves, similar benefits for weight loss and improvement or resolution of type 2 diabetes may be achieved as with gastric bypass surgery. Physicians believe that by creating a physical barrier between the ingested food and selected regions of the gastrointestinal wall, it might be possible to purposefully influence the mechanism of hormonal signal activation originating from the intestine.
  • a known type of endoluminal sleeve relies on metallic expandable structures, such as a stent, to engage the surrounding hollow organ for holding the sleeve in the planned position.
  • metallic expandable structures such as a stent
  • barbs which penetrate the surrounding tissue.
  • the known methods and devices provide a permanent lining of the gastrointestinal tract. Even if, in some embodiments, the fastening means used for securing the endoluminal sleeve are reabsorbable, the healed tissue may tightly bind the lining, so that the endoluminal sleeve is retained over time.
  • the present invention provides for an improved apparatus and method for the transoral, or endoscopic, cutting and removal of an endoluminal lining within a hollow body organ, particularly the gastrointestinal tract, including, but not limited to, the esophagus, stomach, portions of or the entire length of the intestinal tract, etc., unless specified otherwise.
  • the surgeon or endoscopist may insert devices as described below through the patient's mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient's stomach or other intestinal tract, and does not necessarily require any external incision.
  • a method for removing a tubular sleeve or lining from a hollow body organ, particularly from a lumen of the gastrointestinal tract, to which the sleeve or lining has been anchored comprising:
  • the method may encompass inspecting and identifying by an endoscope the area of the endoluminal sleeve or lining to be cut.
  • the distal end of the hollow flexible shaft of the endoluminal cutting device can be positioned close to the anchoring point of the lining, or at any other point, in order to provide for a partial removal of the lining.
  • the method of the invention may include retracting the cut portion of the endoluminal sleeve or lining into the hollow flexible shaft of the endoluminal cutting device, in order to allow a clean and safe extraction of the same from the patient's body.
  • an endoluminal cutting device specifically adapted for removal of an endoluminal sleeve or lining anchored to the wall of a hollow body organ, the device comprising a hollow flexible shaft having a proximal end apt to be handled and operated by an external operator and a distal end comprising a cutting assembly, wherein the said cutting assembly comprises a tubular casing that comprises lining acquisition means and cutting means in a reciprocally moveable relationship.
  • the lining acquisition means comprise a body internally connected with suction means and clamping means for the lining.
  • the blade edge of the cutting means coincide with the edge of the tubular casing outlet and the said lining acquisition means comprise a lining acquisition head of cylindrical shape, the said lining acquisition head being provided with grasping means for the lining.
  • the grasping means comprise a plurality of barbs, hooks, teeth or the like, that are apt to grasp or perforate the lining.
  • figures 1 and 2 show an endoluminal sleeve or lining L applied to different portions of a hollow organ, i.e. a gastro-intestinal tract GI.
  • FIG 3 a particular of the anchoring portion A of the lining L is illustrated.
  • the lining is anchored, for example, by stapling it to the tissue of the body organ.
  • the endoluminal cutting device of the invention comprises a hollow flexible shaft 2 having a proximal end (not shown) apt to be handled and operated by an external operator, i.e. a surgeon, and a distal end 3 comprising a cutting assembly 4.
  • the cutting assembly 4 comprises a tubular casing 5, that may coincide with the distal end 3 of the hollow flexible shaft 2 or be a separate element.
  • the tubular casing 5 will generally have a larger diameter with respect to the said hollow flexible shaft 2 and house a seat 6 wherein cutting means 7 and lining acquisition means 8 are accommodated in a moveable, i.e. slidable, relationship.
  • the cutting means 7 have a circular crown-shaped body 9 with a forward projecting blade edge 10.
  • the blade edge 10 may have a continuous profile or an interrupted profile, i.e. a toothed profile. This latter embodiment will favor the penetration of the blade in the lining and the cutting action.
  • the cutting means 7 have an external diameter that is less than or substantially matches the internal diameter of the tubular casing 5.
  • the cutting means 7 are slidable between a retracted position (see figure 6 ) wherein they are housed inside the seat 6, and an advanced, operative position (not shown), wherein the cutting means 7 are brought to cut the lining L.
  • the cutting means 7 are operatively connected, through suitable actuating means 11, to an actuating mechanism (not shown) that allows the operation of the cutting means 7.
  • the lining acquisition means 8 are stationary or are slidable in a reciprocating direction, to match with the cutting means 7 at a point inside the casing 5.
  • the cutting means 7 are stationary, while the lining acquisition means 8 are slidable as will be described herein below.
  • the lining acquisition means 8 comprise a body 12 which is internally connected with suction means (not shown), for example surgical suction means of a conventional type.
  • the lining acquisition means 8 also comprise clamping means 13 for the lining.
  • the clamping means 13 are mushroom-shaped and have a clamping head 14 of a generally circular shape, which comprises a sharp edge 15 apt to pinch the lining L.
  • the clamping head 15 is connected to a stem 16 that is on its turn connected to actuating means (not shown) apt to move the clamping head 14 between a closure position - wherein the head 14 abuts against the body 12 and clamps the lining therebetween - and an open position - wherein the clamping head 14 is advanced to allow the lining to be sucked by the suctions means described above (see figure 6 )-.
  • the lining acquisition means 8 are generally positioned in such a way that the body 12 ends at the outlet of the tubular casing 5, so that the clamping means 13 emerge from such an end. However, it is also possible that the body 12 protrudes from the outlet of the casing 5.
  • the lining acquisition means 8 are slidable, they can be operated between the said emerging position, i.e. a lining acquisition position - wherein they acquire the lining to be cut - and a retracted, cutting position - wherein the lining is pulled against the blade edge 10.
  • the diameter of the lining acquisition means 8, i.e. of the body 12 and the clamping head 14, is less than the diameter of the cutting means 7, so that they do not interfere each other during operation of the device.
  • a cutting assembly 104 that comprises a tubular casing 105 including cutting means 107 and lining acquisition means 108.
  • the cutting means 107 are circular crown-shaped, wherein the blade edge 110 corresponds to the edge of the tubular casing 105 outlet and can be obtained by beveling the terminal portion of the internal surface of the casing 105.
  • the lining acquisition means 108 comprise a lining acquisition head 114 of cylindrical shape, that is connected to a stem 116.
  • the stem 116 is on its turn operatively connected to an actuating means (not shown) apt to move the head 114 between a lining acquisition position - wherein the lining acquisition head 114 is advanced to pick up the lining - and a retracted, cutting position - wherein the head 114 is pulled inside the tubular casing 105 and the acquired lining is cut while interfering with the blade edge 110 -.
  • the lining acquisition head 114 is provided with grasping means 120 for the lining.
  • the grasping means 120 may comprise a plurality of barbs, hooks, teeth or the like, that are apt to grasp or perforate the lining, so that this latter is kept firmly when it is pulled toward the casing 105.
  • the said grasping means 120 can be fixed or retractable.
  • the grasping means 120 When the grasping means 120 are fixed, they can be made of rigid material or of a flexible material, such as nitinol. When the grasping means 120 are made of a rigid material, the overall diameter of the acquisition head 114 including the grasping means 120 must be the same as or less than the internal diameter of the tubular casing 105. Conversely, when the grasping means 120 are made of a flexible material, they may be configured in order to be bent against the surface of the head 114. In this configuration, the diameter of the acquisition head 114 can be increased to match substantially the internal diameter of the tubular casing 105, but for the residual thickness of the bent grasping means 120.
  • the grasping means 120 are retractable. In this case, they may also be made of a rigid material.
  • a suitable mechanism will be provided to move them between an extended condition (barbs, hooks or teeth protruding outwardly, as shown in figure 8 ) and a retracted condition, wherein they lie on the cylindrical surface of the acquisition head 114.
  • a cam or wedge mechanism of conventional type can be provided to push and pull the grasping means 120 outwardly and inwardly, respectively.
  • the cutting means 107 that have been described above to be integral with the edge of the tubular casing 105, may alternatively be provided internally to the casing, substantially in the same configuration described for the embodiment of figure 6 .
  • the endoluminal cutting device 1 is dimensioned to include a lumen for the introduction of an endoscope.
  • the stem 16, 116 can be dimensioned in order to be hollow and to allow an endoscope to be inserted therein.
  • a further object of the present invention is a method for removing an endoluminal sleeve or lining from a hollow organ, specifically the gastro-intestinal tract or parts thereof, comprising the following steps:
  • step a) also encompasses inspecting and identifying by an endoscope the area of the endoluminal sleeve or lining L to be cut.
  • the distal end 3 of the hollow flexible shaft 2 is positioned just downstream the anchoring point A of the lining L, or in other words distally, with respect to the direction of introduction of the endoluminal cutting device 1.
  • the cutting will occur very close to the anchoring point A, as depicted in figure 7 .
  • the lining acquisition means 8 comprise clamping means 13.
  • step c) comprises sucking the lining L until a substantially circular section thereof is positioned at said clamping means 13 and subsequently clamping the sucked lining section with said clamping means 13; moreover, step d) comprises reciprocally moving the said lining acquisition means 8 with respect to said cutting means 7 until a circular section of the lining is cut.
  • the step of reciprocally moving the said lining acquisition means 8 with respect to said cutting means 7 as defined above may alternatively include: i) pulling backward the lining acquisition means 8 while the cutting means 7 are stationary, or ii) pushing forward the cutting means 7 while the lining acquisition means 8 are stationary, or iii) sliding both the cutting means 7 and the lining acquisition means 8 one toward each other.
  • the lining acquisition means 108 comprise grasping means 120.
  • step c) comprises moving forward the lining acquisition means 108 and optionally operating a revolutionary movement of the same to contact a substantially circular portion of the endoluminal sleeve L and to grasp the lining by the said grasping means 120; moreover, step d) comprises moving the lining acquisition means 108 backward until the blade edge 110 of the cutting means 107 circularly cuts the lining L.
  • step c) can optionally include sucking the lining L through suitable suction means, such as a surgical suction tube, in order to detach the lining from the tissue of the hollow body organ which it is adhered to.
  • suitable suction means such as a surgical suction tube
  • step d) can optionally include moving backward the lining acquisition means 8, 108 after the cut has been made, in order to retract the cut portion of the endoluminal sleeve or lining L into the hollow flexible shaft 2 of the device.
  • the cut portion of the endoluminal sleeve or lining L is released from the lining acquisition means 8, 108 and is left to be eliminated by the patient's body through natural peristalsis.
  • Releasing of the lining can be achieved by simply opening the clamping means 13 in the embodiment of figure 6 or scraping the surface of the cut lining portion against the internal surface of the tubular casing 105 in the embodiment of figure 8 .
  • the device and method of the present invention provide an easy and safe way to remove an endoluminal sleeve with minimally invasive impact to the patient.
  • the removal of the lining can be performed without the need of a surgical intervention, by a simple endoluminal operation.
  • the blade edge of the cutting means can be kept inside the tubular casing, so that the cutting operation is performed inside the casing thus avoiding the risk of cutting or damaging the tissue of the body organ.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)
EP10193368A 2010-12-01 2010-12-01 Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux Withdrawn EP2460494A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP10193368A EP2460494A1 (fr) 2010-12-01 2010-12-01 Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux
PCT/EP2011/071345 WO2012072662A1 (fr) 2010-12-01 2011-11-30 Dispositif de coupe de gaine endoluminale et procédé pour enlever un revêtement d'un organe creux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP10193368A EP2460494A1 (fr) 2010-12-01 2010-12-01 Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux

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EP2460494A1 true EP2460494A1 (fr) 2012-06-06

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EP10193368A Withdrawn EP2460494A1 (fr) 2010-12-01 2010-12-01 Dispositif de découpe de manchon endoluminaire et procédé de suppression de revêtement d'un organe creux

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EP (1) EP2460494A1 (fr)
WO (1) WO2012072662A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350099B2 (en) 2006-09-01 2019-07-16 Ethicon Endo-Surgery, Inc. Devices and methods for anchoring an endoluminal sleeve in the GI tract
US9456917B2 (en) 2013-08-28 2016-10-04 Ethicon Endo-Surgery, Inc. Endoscopic transoral duodenal sleeve applier

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6309399B1 (en) * 1996-07-17 2001-10-30 Scimed Life Systems, Inc. Atherectomy device having trapping and excising means for removal of plaque from the aorta and other arteries
US20070083271A1 (en) * 2002-12-02 2007-04-12 Levine Andy H Anti-obesity devices
US7220237B2 (en) 2002-10-23 2007-05-22 Satiety, Inc. Method and device for use in endoscopic organ procedures

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6309399B1 (en) * 1996-07-17 2001-10-30 Scimed Life Systems, Inc. Atherectomy device having trapping and excising means for removal of plaque from the aorta and other arteries
US7220237B2 (en) 2002-10-23 2007-05-22 Satiety, Inc. Method and device for use in endoscopic organ procedures
US20070233162A1 (en) * 2002-10-23 2007-10-04 Jamy Gannoe Method and device for use in endoscopic organ procedures
US20070083271A1 (en) * 2002-12-02 2007-04-12 Levine Andy H Anti-obesity devices

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Publication number Publication date
WO2012072662A1 (fr) 2012-06-07

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